Device |
automated system for sample preparation and identification of microorganisms from cultured isolates by mass spectrometry |
Definition |
An automated in vitro diagnostic system to prepare colonies of microorganisms grown on solid culture media from human specimens for qualitative identification and differentiation using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS). |
Physical State |
In vitro diagnostic device |
Technical Method |
Matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) microorganism identification |
Target Area |
Identification and differentiation of microorganisms cultured from human specimens |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | QQV |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3378
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |